NCT05284799

Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.

Phase 2a, Randomized, Double-blind (Double-dummy), Controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and a Quadrivalent Inactivated Influenza Vaccine Given Intramuscularly as 2 Separate Injections in the Same Arm, in Comparison to Co-administration of Quadrivalent Inactivated Influenza Vaccine and Placebo and to Co-administration of OVX836 and Placebo Given Intramuscularly in Healthy Subjects.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Osivax · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.

Detailed description

This trial is a Phase 2a, randomized, double-blind, controlled study in 180 adult subjects to compare the immunogenicity and the safety of the concomitant administration (given intramuscularly, in healthy subjects, as 2 separate injections in the same arm) of: * OVX836 influenza vaccine and a Quadrivalent Inactivated Influenza Vaccine * Quadrivalent Inactivated Influenza Vaccine and placebo * OVX836 influenza vaccine and placebo

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	OVX836 480µg	One single administration intramuscularly at Day 1
BIOLOGICAL	Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)	One single administration intramuscularly at Day 1
BIOLOGICAL	Placebo	One single administration intramuscularly at Day 1

Timeline

• Start date: 2022-05-09
• Primary completion: 2022-07-19
• Completion: 2022-12-09
• First posted: 2022-03-17
• Last updated: 2024-10-31

Locations

1 site across 1 country: Australia